# K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System - Pathway: 510(k) (Traditional) - Applicant: Globus Medical, Inc. - Decided: Nov 6, 2018 after 118 days - Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body) - Device class: 2 - Regulation: 21 CFR 888.3060 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 10 generations back to K000319 (2000). 153 ancestors in all. 4 later devices descend from it; 2 cite it directly. 0 of 158 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K040721: Assure Anterior Cervical Plate System, Globus Medical, Inc. (2004) Summary page 13. - K070775: Modification to: Providence Anterior Cervical Plate System, Globus Medical, Inc. (2007) Summary page 14. - K081391: Vip Anterior Cervical Plate System, Globus Medical, Inc. (2008) Summary page 14. - K092146: Xtend Anterior Cervical Plate System, Globus Medical, Inc. (2009) Summary page 14. - K121049: Unify Dynamic Anterior Cervical Plate System, Globus Medical, Inc. (2012) Summary page 14. - K133567: Unify (R) Dynamic Anterior Cervical Plate System, Globus Medical, Inc. (2014) Summary page 14. - K062836: Citadel Anterior Lumbar Plate System, Globus Medical, Inc. (2006) Summary page 14. - K092108: Truss Thoracolumbar Plate System, Globus Medical, Inc. (2009) Summary page 14. - K120092: Plymouth Thoracolumbar Plate System, Globus Medical, Inc. (2012) Summary page 14. - K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011) Summary page 14. - K132191: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2013) Summary page 14. - K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System, Globus Medical, Inc. (2018) Summary page 14. - K080664: Relieve Laminoplasty Fixation System, Globus Medical, Inc. (2008) Summary page 14. ## Most influential descendants - K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own - K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own - K233735: ADIRA™ Lateral Plate System (2024), 0 descendants of its own - K211205: Prase-C Anterior Cervical Plate System (2021), 0 descendants of its own ## Indications for use The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The PROVIDENCE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The VIP® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The XTEND® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The UNIFY® Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis. The CITADEL® Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The TRUSS® Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The PLYMOUTH® Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use. The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord. Source page: https://510kreport.com/device/K181846 Methodology: https://510kreport.com/methodology